BCM to lead cardiac innovation AI-driven drug safety…

Baylor College of Medicine will be a site for a new multi-institution project aimed at investigating preclinical drug safety assessments. The project, known as DATAMAP, the Digital Acceleration of Toxicity Assessment with Mechanistic and AI-driven Predictions, is focused on accelerating the development of safer therapeutics.

Dr. Tamer Mohamed, associate professor in the Michael E. DeBakey Department of Surgery and director of cardiac regeneration, will serve as principal investigator for Baylor and co-investigator for the national project team, which was created and led by Inductive Bio, an AI drug discovery partner that helps biopharma teams design and optimize higher quality drugs. The contract award of up to 21 million is from the Advanced Research Projects Agency for Health (ARPA-H) Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program.

The project's goal is to develop validated, FDA-qualified in silico organ toxicity models that integrate artificial intelligence with physiology-based mathematical modeling. These models will predict human drug toxicity for small molecules, with a focus on the liver and heart, organs most often implicated in clinical trial failure due to toxicity.

"Members of Baylor's Department of Surgery will be able to contribute their unique expertise in cardiac tissue modeling. We will lead the development and optimization of state-of-the-art human heart slice culture systems to assess drug-induced cardiotoxicity," Mohamed said. "By combining advanced cardiac tissue engineering with AI-driven analytics, we aim to set a new standard for predicting drug safety and reducing the risk of adverse cardiac events in clinical trials."

His team at Baylor will refine protocols for preparing and maintaining human cardiac slices, integrating multi-electrode array (MEA) technology and optical strain/contractility analysis to capture real-time, high-resolution functional data. This innovative approach will generate critical data for building and validating the DATAMAP cardiac toxicity prediction models. This is one of the first ARPA-H contracts awarded for work being done at Baylor.

"This achievement reflects Baylor's commitment to advancing biomedical innovation and patient safety," said Dr. Todd K. Rosengart, professor and DeBakey-Bard Chair of the Michael E. DeBakey Department of Surgery. "We are proud of Dr. Mohamed and his team's leadership in this national effort."

For DATAMAP, Inductive Bio brought together a multidisciplinary team including leaders in AI, drug development, organoid and tissue modeling and regulatory science from Amgen, Cincinnati Children's Hospital Medical Center, Torch Bio, as well as Baylor's involvement.

CATALYST aims to revolutionize preclinical drug safety prediction by developing human-based models that accurately estimate toxicity and safety profiles for drug candidates. ARPA-H's investment in DATAMAP will enable the team to build a secure, scalable data repository, generate high-quality multi-system data, and develop advanced AI models to reduce reliance on animal testing and improve the accuracy of preclinical safety assessments.